search
Back to results

BinaxNow COVID-19 IgG Rapid Test Device and Antibody Self Test

Primary Purpose

COVID-19 Respiratory Infection

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
The BinaxNOW™ Antibody Tests measure IgG antibodies against SARS-CoV-2.
Sponsored by
Abbott Rapid Diagnostics Jena GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for COVID-19 Respiratory Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Participant is 18 years of age or older.

  2. Evaluable individuals with a prior confirmed SARS-CoV-2 infection with prior COVID-19 symptoms with symptoms onset > 14 days prior to the study, or symptoms onset 8-14 days prior to the study, or symptoms onset 0-7 days prior to study.OR

    Evaluable individuals confirmed negative by SARS-CoV-2 RT-PCR using a sample obtained within 7 days prior to or on the day of the study.

  3. Participant agrees to complete all aspects of the study.

Exclusion Criteria:

  1. Participant has already participated in this study on a previous occasion.
  2. Participant is enrolled in a study to evaluate a new drug.
  3. Participant has a visual impairment that cannot be restored using glasses or contact lenses.
  4. Participant is unable or unwilling to provide informed consent.
  5. Participant is a vulnerable person as deemed unfit for the study by the Principal Investigator.
  6. Participant has a condition deemed unfit to safely perform the test by the investigator.
  7. Participant is a practising health-care professional or laboratory scientist / technician.

Sites / Locations

  • Rush University Medical Center
  • Duke University Health System
  • Urgent Care Clinical Trials
  • Urgent Care Clinical Trials at Complete Health Partners
  • Urgent Care Clinical Trials

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BinaxNow Covid-19 Antibody test

Arm Description

The BinaxNOW™ Antibody Tests measure SARS-CoV-2 S-IgG antibodies.

Outcomes

Primary Outcome Measures

Clinical performance of the BinaxNOW™ COVID-19 IgG Rapid Test
to evaluate the clinical performance of the BinaxNOW™ COVID-19 IgG Rapid Test Device when used by a professional user.
Clinical performance of the BinaxNOW™ COVID-19 Antibody Self-Test
to evaluate the clinical performance of the BinaxNOW™ COVID-19 Antibody Self-Test when used by a lay person.

Secondary Outcome Measures

Professional user usability
Evaluation of the usability of the BinaxNOW™ COVID-19 IgG Rapid Test Device when used by a Professional User
Self Test user usability
Evaluation of the usability of the BinaxNOW™ COVID-19 Antibody Self-Test when used by a lay person.
Matrix Equivalence Professional Use
Validation of the Matrix Equivalence between the Fingerstick Whole Blood and Plasma samples when used with the BinaxNOW COVID-19 IgG Rapid Test Device.
Diagnostic sensitivity and specificity
To determine the diagnostic sensitivity, specificity and overall agreement of the BinaxNOW™ COVID-19 Antibody Self Test as performed by lay users in comparison with the BinaxNOW™ COVID-19 IgG Rapid Test Device as performed by professional user.

Full Information

First Posted
July 1, 2021
Last Updated
May 6, 2022
Sponsor
Abbott Rapid Diagnostics Jena GmbH
search

1. Study Identification

Unique Protocol Identification Number
NCT04959760
Brief Title
BinaxNow COVID-19 IgG Rapid Test Device and Antibody Self Test
Official Title
Clinical Evaluation of the BinaxNOW™ COVID-19 IgG Rapid Test Device and the BinaxNOW™ COVID-19 Antibody Self Test Clinical Study Protocol
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
June 3, 2021 (Actual)
Primary Completion Date
January 20, 2022 (Actual)
Study Completion Date
January 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Rapid Diagnostics Jena GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Performance evaluation of the BinaxNOW™ COVID-19 IgG Rapid Test Device (Professional Use) and with BinaxNOW™ COVID-19 Antibody Self Test wehn used with fingerstick capillary whole blood and plasma samples. The BinaxNOW™ Antibody Tests are lateral flow tests that measure SARS-CoV-2 IgG antibodies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Respiratory Infection

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
Operator of the device will be blinded to the outcome
Allocation
N/A
Enrollment
263 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BinaxNow Covid-19 Antibody test
Arm Type
Experimental
Arm Description
The BinaxNOW™ Antibody Tests measure SARS-CoV-2 S-IgG antibodies.
Intervention Type
Diagnostic Test
Intervention Name(s)
The BinaxNOW™ Antibody Tests measure IgG antibodies against SARS-CoV-2.
Intervention Description
The BinaxNOW™ Antibody Tests measure IgG antibodies against SARS-CoV-2 in fingestick capillary blood and plasma samples.
Primary Outcome Measure Information:
Title
Clinical performance of the BinaxNOW™ COVID-19 IgG Rapid Test
Description
to evaluate the clinical performance of the BinaxNOW™ COVID-19 IgG Rapid Test Device when used by a professional user.
Time Frame
Through study completion, an average of 6 months
Title
Clinical performance of the BinaxNOW™ COVID-19 Antibody Self-Test
Description
to evaluate the clinical performance of the BinaxNOW™ COVID-19 Antibody Self-Test when used by a lay person.
Time Frame
Through study completion, an average of 6 months
Secondary Outcome Measure Information:
Title
Professional user usability
Description
Evaluation of the usability of the BinaxNOW™ COVID-19 IgG Rapid Test Device when used by a Professional User
Time Frame
Through study completion, an average of 6 months
Title
Self Test user usability
Description
Evaluation of the usability of the BinaxNOW™ COVID-19 Antibody Self-Test when used by a lay person.
Time Frame
Through study completion, an average of 6 months
Title
Matrix Equivalence Professional Use
Description
Validation of the Matrix Equivalence between the Fingerstick Whole Blood and Plasma samples when used with the BinaxNOW COVID-19 IgG Rapid Test Device.
Time Frame
Through study completion, an average of 6 months
Title
Diagnostic sensitivity and specificity
Description
To determine the diagnostic sensitivity, specificity and overall agreement of the BinaxNOW™ COVID-19 Antibody Self Test as performed by lay users in comparison with the BinaxNOW™ COVID-19 IgG Rapid Test Device as performed by professional user.
Time Frame
Through study completion, an average of 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Participant is 18 years of age or older. Evaluable individuals with a prior confirmed SARS-CoV-2 infection with prior COVID-19 symptoms with symptoms onset > 14 days prior to the study, or symptoms onset 8-14 days prior to the study, or symptoms onset 0-7 days prior to study.OR Evaluable individuals confirmed negative by SARS-CoV-2 RT-PCR using a sample obtained within 7 days prior to or on the day of the study. Participant agrees to complete all aspects of the study. Exclusion Criteria: Participant has already participated in this study on a previous occasion. Participant is enrolled in a study to evaluate a new drug. Participant has a visual impairment that cannot be restored using glasses or contact lenses. Participant is unable or unwilling to provide informed consent. Participant is a vulnerable person as deemed unfit for the study by the Principal Investigator. Participant has a condition deemed unfit to safely perform the test by the investigator. Participant is a practising health-care professional or laboratory scientist / technician.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon Kordowich
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Duke University Health System
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Urgent Care Clinical Trials
City
Powdersville
State/Province
South Carolina
ZIP/Postal Code
29611
Country
United States
Facility Name
Urgent Care Clinical Trials at Complete Health Partners
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37209
Country
United States
Facility Name
Urgent Care Clinical Trials
City
Dallas
State/Province
Texas
ZIP/Postal Code
75204
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

BinaxNow COVID-19 IgG Rapid Test Device and Antibody Self Test

We'll reach out to this number within 24 hrs